Face transplant with donor tissue and bone marrow stem cell infusion
Official title: Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
Run by Centre Hospitalier Universitaire, Amiens · NCT02818400 · Data updated 2026-11-12
This will try face transplantation using donor facial tissue plus a bone marrow stem cell infusion for people with severe facial tissue loss that cannot be repaired with conventional surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | November 2009 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT02818400 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe, unrepairable facial tissue loss who are medically and psychiatrically stable and meet the study's cardiac and renal function criteria would be considered candidates.
✕Probably not a fit
Patients whose facial defects can be managed with standard reconstructive surgery, or those with active or recent malignancy, severe psychiatric illness, poor cardiac or renal function, or uncontrolled hypertension are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective series plans to enroll five patients over three years to test composite facial allotransplantation combined with bone marrow stem cell infusion to create microchimerism. Patients will receive standard immunosuppression alongside the donor facial graft and a planned stem cell infusion intended to improve mucocutaneous tolerance. Outcomes will include surgical feasibility, functional and aesthetic results, and safety monitored through clinical follow-up, imaging, and biopsy as needed. The protocol excludes patients whose defects are repairable by conventional reconstruction or who have significant medical or psychiatric contraindications.
Why it matters
Potential benefit: If successful, this approach could restore facial form and function in people with injuries that cannot be fixed by conventional reconstructive techniques.
How similar studies have gone: Several international teams have performed face transplants with reported functional and aesthetic gains, but the routine use of bone marrow stem cell infusion to induce microchimerism is less well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with loss of unrepairable substance by conventional techniques shreds, at the front Exclusion Criteria: * Facial lesions repaired by conventional reconstructive surgery techniques * History of malignancy in remission for less than 5 years * Malignant neoplasm undergoing changes * Severe psychiatric history * Patients above a score of 2 on the scale of the ASA (American Society of Anesthesiology) * Patients above a grade 1 in the classification NYHA ( New York Heart Association ) * insufficient with renal creatinine clearance less than 70 mL / min or presence of a proteinuria * Severe hypertension
Where it's running
-
CHU Amiens
Amiens, France Recruiting
Study contacts
- Principal investigator: Bernard DEVAUCHELLE, Md, PhD — CHU Amiens
- Study coordinator: Bernard DEVAUCHELLE, Md, PhD
- Email: devauchelle.bernard@chu-amiens.fr
- Phone: +33 3 22 08 90 71
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.